The following data is part of a premarket notification filed by American Orthodontics with the FDA for Preformed Template For Tooth Positioner.
| Device ID | K891328 |
| 510k Number | K891328 |
| Device Name: | PREFORMED TEMPLATE FOR TOOTH POSITIONER |
| Classification | Positioner, Tooth, Preformed |
| Applicant | AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan, WI 53081 |
| Contact | Paul Riddle |
| Correspondent | Paul Riddle AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan, WI 53081 |
| Product Code | KMY |
| CFR Regulation Number | 872.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-10 |
| Decision Date | 1989-03-31 |